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Follow-up of Inflammatory Responses and Multiorgan Outcomes FoLlowing Neonatal Brain injurY

NCT04816331 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-03-25

No results posted yet for this study

Summary

Babies who have brain injury also frequently have involvement of their kidneys, lung and heart. Although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. The investigators aim to develop and implement guidelines for health care workers and families on Followup after Neonatal Brain Injury.

Inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. The investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. By understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.

Conditions

  • Neonatal Encephalopathy

Interventions

OTHER

Medical records and clinical measurements

Medical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination. Questionnaires for caregivers to assess social-emotional and adaptive domains. Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing. Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling.

Sponsors & Collaborators

  • Health Research Board, Ireland

    collaborator OTHER

  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Eleanor Molloy, Prof. · Professor of Paediatrics & Child Health, Paediatrics

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2022-06-30
Completion
2022-09-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816331 on ClinicalTrials.gov